MORPHINE SULFATE
- Product NDC
- 68382-905
- 11-digit product format
- 683820905
- Labeler code
- 68382
- Product ID
- 68382-905_9de8f079-429a-4a8f-8c65-9a71ba35d589
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MORPHINE SULFATE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals (USA) Inc.
- Application
- ANDA076720
- Marketing category
- ANDA
- Marketing start
- 2015-07-09
- Marketing end
- 0000-00-00
- Substance
- MORPHINE SULFATE
- Active strength
- 60 mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68382-905-01 | MORPHINE SULFATE | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| MORPHINE SULFATE | ACTIVE INGREDIENT | X3P646A2J0 | MORPHINE SULFATE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC. ] | 2 | |
| MORPHINE | ACTIVE MOIETY | 76I7G6D29C | MORPHINE SULFATE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC. ] | 2 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | MORPHINE SULFATE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC. ] | 2 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | MORPHINE SULFATE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC. ] | 2 | |
| D&C RED NO. 27 | INACTIVE INGREDIENT | 2LRS185U6K | MORPHINE SULFATE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC. ] | 2 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | MORPHINE SULFATE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC. ] | 2 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | MORPHINE SULFATE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC. ] | 2 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | MORPHINE SULFATE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC. ] | 2 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | MORPHINE SULFATE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC. ] | 2 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | MORPHINE SULFATE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC. ] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | MORPHINE SULFATE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC. ] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | MORPHINE SULFATE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC. ] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | MORPHINE SULFATE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC. ] | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | MORPHINE SULFATE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC. ] | 2 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | MORPHINE SULFATE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC. ] | 2 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | MORPHINE SULFATE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC. ] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | MORPHINE SULFATE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC. ] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68382-905 | MORPHINE SULFATE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC. ] | 9 | Legacy NDC, 1 package rows | 20211218_7fc20bfa-86c2-40a0-be8e-8f5447bcee44.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68382-905-01 | 68382090501 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-905-01) | 2015-07-09 | 0000-00-00 | No | No | Current |